Label: SATOS CORN AND CALLUS REMOVER- salicylic acid liquid

  • NDC Code(s): 49873-078-01
  • Packager: Sato Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2023

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  • ACTIVE INGREDIENT

    Active ingredient

    Salicylic acid 12%

  • PURPOSE

    Purpose

    Salicylic acid...Corn and callus remover

  • INDICATIONS & USAGE

    Uses
    ■ for the removal of corns and callus
    ■ relieves pain by removing corns

  • WARNINGS




    For external use only

    Flammable

    ■ keep away from fire or flame

    ■ cap bottle tightly and store at room temperature away from heat.

    Do not use

    ■ on irritated skin

    ■ on any area that is infected or reddened

    ■ if you are a diabetic

    ■ if you have poor blood circulation

    When using this product

    ■ avoid inhaling vapors

    Stop use and ask a doctor if discomfort persists.


    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    ■ wash affected area and dry thoroughly
    ■ apply one drop at a time with applicator to sufficiently cover each corn/callus
    ■ let dry
    ■ repeat this procedure once or twice daily as needed for up to 14 days (until corn/callus is removed)
    ■ may soak corn/callus in warm water for 5 minutes to assist in removal

  • INACTIVE INGREDIENT

    Inactive ingredients  collodion, lactic acid   

  • PRINCIPAL DISPLAY PANEL

    satoliqcorncart.jpg carton


  • INGREDIENTS AND APPEARANCE
    SATOS CORN AND CALLUS REMOVER 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-078
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID12 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PYROXYLIN (UNII: KYR8BR2X6O)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-078-011 in 1 CARTON09/19/1987
    19.85 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03009/19/1987
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-078) , label(49873-078) , pack(49873-078)
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